The meeting was arranged in order to ask AEMPS some guidance in order to prepare the coming submission of the phase IIa clinical trial inside the iHIVARNA project.
EXTEDO and ASPHALION invite you to their webinar “Pharmacovigilance Inspection Readiness in Spain: Electronic Safety Database” on 23 May 2016.
Asphalion is happy to announce that it has been certified by Health Canada to perform electronic submission by the Gateway.
The first results with the first vaccinated patients are quite optimistic and the discussion on the phase II clinical trial was productive, setting the foundations for this second part of the project.
As part of the European Medicines Agency strategy to reinforce regulatory support and improve timely access to medicines, a new scheme will be launched in Q1 2016 to further support development of new medicines addressing major public health needs.
If you have a project that falls under the eligibility criteria for Horizon 2020 Programme, Asphalion is available to provide you with our regulatory expertise.
We are very pleased to have participated in this charity project where the main objective has been to help recover Nepal after the earthquake in April 2015.
The phased wise implementation of ISO IDMP will probably mean first submission of data end 2017 or 2018.
However, this is depending on the finalisation of the ISO standards